Dalbavancin for Infections of the Skin COmpared
to Vancomycin at an Early Response

Two multicenter, randomized, double-blind, double-dummy, noninferiority trials of
similar design with an active comparator (vancomycin/linezolid)1,3

The ITT population included 1312 randomized adult patients* with documented ABSSSI1

Patient selection criteria: patients with cellulitis, abscess, or wound infection
with a lesion size ≥75 cm2 and at least one systemic sign of disease at baseline, defined as1:

Temperature ≥38°C (100.4°F)

Elevated WBC count (>12,000 cells/mm3), or

10% or more band forms on WBC differential

Patients with creatinine clearance <30 mL/min had their dose adjusted. Approximately 5% of patients
also received a protocol-specified empiric course of treatment with intravenous aztreonam for coverage
of Gram-negative pathogens.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial
agents, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible
bacteria.

IMPORTANT SAFETY INFORMATION

Contraindications

DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.

Warnings and Precautions

Hypersensitivity Reactions

Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including
DALVANCE. Exercise caution in patients with known hypersensitivity to glycopeptides due to the possibility of cross-sensitivity.
If an allergic reaction occurs, treatment with DALVANCE should be discontinued.

Infusion-related Reactions

Rapid intravenous infusion of DALVANCE can cause reactions, including flushing of the upper body, urticaria, pruritus, rash,
and/or back pain.

Hepatic Effects

ALT elevations with DALVANCE treatment were reported in clinical trials.

Clostridium difficile-associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including
DALVANCE, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

Development of Drug-resistant Bacteria

Prescribing DALVANCE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

The most common adverse reactions in patients treated with DALVANCE were nausea (4.7%), headache (3.8%), and diarrhea
(3.4%).

Use in Specific Populations

There have been no adequate and well-controlled studies with DALVANCE in pregnant or nursing women.
DALVANCE should only be used if the potential benefit justifies the potential risk in these populations.

In patients with renal impairment whose known creatinine clearance is less than 30 mL/min and who are not receiving
regularly scheduled hemodialysis, the recommended regimen of DALVANCE is 1125 mg, administered as a single
dose, or 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving
regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of hemodialysis.

Caution should be exercised when prescribing DALVANCE to patients with moderate or severe hepatic impairment
(Child-Pugh Class B or C) as no data are available to determine the appropriate dosing in these patients.

The information provided in this site is intended for US healthcare professionals only.
The products described on this site may have different product labeling in countries outside of the United States.

DALVANCE IS INDICATED
for the treatment of adult patients with acute bacterial skin and
skin structure infections (ABSSSI) due to designated susceptible
Gram-positive pathogens.
See full Indication and Usage below.

IMPORTANT SAFETY INFORMATION

Contraindications

DALVANCE is contraindicated in patients with known hypersensitivity to dalbavancin.

Show More

Warnings and Precautions

Hypersensitivity Reactions

Serious hypersensitivity (anaphylactic) and skin reactions have been reported with glycopeptide antibacterial agents, including
DALVANCE. Exercise caution in patients with known hypersensitivity to glycopeptides due to the possibility of cross-sensitivity.
If an allergic reaction occurs, treatment with DALVANCE should be discontinued.

Infusion-related Reactions

Rapid intravenous infusion of DALVANCE can cause reactions, including flushing of the upper body, urticaria, pruritus, rash,
and/or back pain.

Hepatic Effects

ALT elevations with DALVANCE treatment were reported in clinical trials.

Clostridium difficile-associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including
DALVANCE, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

Development of Drug-resistant Bacteria

Prescribing DALVANCE in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions

The most common adverse reactions in patients treated with DALVANCE were nausea (4.7%), headache (3.8%), and diarrhea
(3.4%).

Use in Specific Populations

There have been no adequate and well-controlled studies with DALVANCE in pregnant or nursing women.
DALVANCE should only be used if the potential benefit justifies the potential risk in these populations.

In patients with renal impairment whose known creatinine clearance is less than 30 mL/min and who are not receiving
regularly scheduled hemodialysis, the recommended regimen of DALVANCE is 1125 mg, administered as a single
dose, or 750 mg followed one week later by 375 mg. No dosage adjustment is recommended for patients receiving
regularly scheduled hemodialysis, and DALVANCE can be administered without regard to the timing of hemodialysis.

Caution should be exercised when prescribing DALVANCE to patients with moderate or severe hepatic impairment
(Child-Pugh Class B or C) as no data are available to determine the appropriate dosing in these patients.